DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Examiner acknowledges claims 1-17, 19-20, 23, 25 and 37 are cancelled as well as claims 39-40 are withdrawn. In order to aid in expediting prosecution, the Office suggests that withdrawn claims 39 and 40 are cancelled by the next response.
Applicant’s arguments in view of the claim amendments, see page 7 of the Remarks, filed 15 June 2026, with respect to the 35 U.S.C. 112(a) rejection of claim 18 have been fully considered and are persuasive. The 35 U.S.C. 112(a) rejection of claim 18 has been withdrawn.
Applicant's arguments filed 15 June 2026 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 103 rejection of claims 18, 21-22, 24, 26-36 and 38 seen on pages 7-9 of the Remarks:
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, the Examiner respectfully disagrees with the Applicant that Hurst, Bungay, Niazi, and Windahl do not teach or suggest “the mechanical interaction device includes one or more movable parts configured to apply at least 5 deformations that each deform the first container by at least 5%”.
Hurst disclosed the at least one first container that is a deformable, single-use separation resin storage container (Paragraphs [0155] and [0195]). Windahl teaches a system for transferring resin between two containers (Paragraphs [0013-0014]). Bungay teaches a container system (5, Figure 1) that contacts and deforms the first container with one or more moveable parts (Paragraph [0040] and [0042]). Niazi teaches a separative bioreactor comprising a mechanical interaction device that deforms the container (Paragraph [0075]).
Both Niazi and Bungay teach that a flexible container is in contact with a mechanical interaction device. Bungay teaches that the container may be squeezed and released to distort the shape of the container to provide agitation to the bioprocessing fluids (Paragraph [0040]). Niazi teaches that the flapper compresses the bag causing the media within the bag to mix (Paragraph [0075]). In both references, the container undergoes some deformation to mix the media within. The range of at least 5 deformations that each deform the first container by at least 5% was taught through design choice. While the Applicant on page 9 of the Remarks provide a citation to where criticality or advantages for the range occur, the language used in the Specification submitted 3 March 2022 on page 16, lines 7-14 and page 17, lines 14-24 uses the word “may” which lessens the criticality of the range. The reduction of criticality for the range makes it read dependent on the fluid within the first container. Additionally, the deformation of the volume is not claimed within the claims submitted 15 June 2026.
As such, the rejections for claims 18, 21-22, 24, 26-36 and 38 are being maintained as they will be explained in details in the present Office Action.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claim Objections
Claim 36 is objected to because of the following informalities:
Line 3, “which adaptor” should be amended to –which the adaptor--. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a mechanical interaction device in claim 18 and a pressure difference generating device in claims 18 and 36.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 18, 21, 24, 29, 31, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Hurst (US 20040245124 A1) in view of Bungay (US 20080186802 A1) in further view of Niazi (US 20110198286 A1) and Windahl (US 20070090053 A1).
Regarding Claim 18:
Hurst discloses a container, comprising:
at least one first container (30, Figure 1) which is a deformable, single-use separation resin storage container (Paragraphs [0155] and [0195]) comprising a predetermined volume of separation resin and a predetermined volume of storage solution (Paragraph [0191], the dry material is the separation resin and the process compatible solution is the storage solution creates a slurry), said first container further comprising an outlet port (50, Figure 1) arranged for transferring the separation resin (Paragraph [0108]).
Hurst does not disclose:
A system for transferring separation resin between at least two containers;
a mechanical interaction device provided in connection with an outside of the first container such that it provides a deformation to a lower side of said first container, wherein the mechanical interaction device includes one or more movable parts configured to apply at least 5 deformations that each deform the first container by at least 5%, and wherein the deformation is effective to fluidize the separation resin with the storage solution to form a resin slurry;
a second container comprising an inlet port which is fluidically connected to the outlet port of said at least one first container; and
a pressure difference generating device configured for transferring separation resin from the at least one first container to the second container by generating a pressure difference between an interior of the second container and an interior of the first container wherein the pressure is lower in the second container;
wherein the pressure difference generating device is at least one vacuum production device connected to the second container and arranged for providing a degree of vacuum in the second container at least during a transferring of the separation resin from the at least one first container to the second container; and
wherein the mechanical interaction device is provided in a storage bin in which the first container is provided, and the mechanical interaction device is a moveable bottom part in the storage bin.
Bungay teaches a container system (5, Figure 1, the system is the container system):
a mechanical interaction device (30 and 35, Figure 1, the mixing arms and connecting bar are the mechanical interaction device) provided in connection with an outside of the first container (14, Figure 1) such that it provides a deformation to a lower side of said first container (Paragraph [0040], the mechanical interaction device provides distortion to the outside the lower side of the container), wherein the mechanical interaction device includes one or more movable parts (30, Figure 1) configured to repeatedly contact and deform the first container (Paragraphs [0040] and [0042], the first container has intermittent contact and the mechanical interaction device can be controlled to have various contact with the container); and
wherein the mechanical interaction device (30 and 35, Figure 1) is provided in a storage bin (20, Figure 1, the housing is the storage bin) in which the first container (14, Figure 1) is provided, and the mechanical interaction device is a moveable bottom part in the storage bin (Figure 1, the mechanical interaction device is a moveable bottom part in the housing).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst to include a mechanical interaction device provided in connection with an outside of the first container such that it provides a deformation to a lower side of said first container, wherein the mechanical interaction device includes one or more movable parts configured to repeatedly contact and deform the first container the mechanical interaction device is provided in a storage bin in which the first container is provided, and the mechanical interaction device is a moveable bottom part in the storage bin as taught by Bungay with the motivation to cause motion within the container to mix the materials within a controlled manner to prevent potential human error.
Hurst and Bungay do not teach:
A system for transferring separation resin between at least two containers;
a mechanical interaction device provided in connection with an outside of the first container such that it provides a deformation to a lower side of said first container, wherein the mechanical interaction device includes one or more movable parts configured to apply at least 5 deformations that each deform the first container by at least 5%, and wherein the deformation is effective to fluidize the separation resin with the storage solution to form a resin slurry;
a second container comprising an inlet port which is fluidically connected to the outlet port of said at least one first container; and
a pressure difference generating device configured for transferring separation resin from the at least one first container to the second container by generating a pressure difference between an interior of the second container and an interior of the first container wherein the pressure is lower in the second container;
wherein the pressure difference generating device is at least one vacuum production device connected to the second container and arranged for providing a degree of vacuum in the second container at least during a transferring of the separation resin from the at least one first container to the second container.
Niazi teaches a separative bioreactor, comprising:
a mechanical interaction device (7, Figure 1) provided in connection with an outside of the first container (1, Figure 1) such that it provides a deformation to a lower side of said first container, wherein the mechanical interaction device includes one or more movable parts configured to repeatedly contact and deform the first container (Figure 1 and Paragraph [0075], the flapper is the moveable part and mechanical interaction device that strikes the flexible bag periodically where the compression is applied to the lower side of the first container), and wherein the deformation is effective to fluidize the separation resin with the storage solution to form a resin slurry (Paragraph [0075], the flapper creates a wave within the bag until the mixing is smooth); and
wherein the mechanical interaction device (7, Figure 1) is provided in a storage bin (9 and 10, Figure 1) in which the first container (1, Figure 1) is provided.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the separation resin in the device of Hurst and Bungay to include a mechanical interaction device provided in connection with an outside of the first container such that it provides a deformation to a lower side of said first container, wherein the mechanical interaction device includes one or more movable parts configured to repeatedly contact and deform the first container, the deformation is effective to fluidize the separation resin with the storage solution to form a resin slurry, and the mechanical interaction device is provided in a storage bin in which the first container is provided as taught by Niazi with the motivation to ensure no unmixed media is within the bag to allow for the binding within the mixture.
Hurst, Niazi, and Bungay do not teach:
A system for transferring separation resin between at least two containers;
wherein the mechanical interaction device includes one or more movable parts configured to apply at least 5 deformations that each deform the first container by at least 5%;
a second container comprising an inlet port which is fluidically connected to the outlet port of said at least one first container; and
a pressure difference generating device configured for transferring separation resin from the at least one first container to the second container by generating a pressure difference between an interior of the second container and an interior of the first container wherein the pressure is lower in the second container;
wherein the pressure difference generating device is at least one vacuum production device connected to the second container and arranged for providing a degree of vacuum in the second container at least during a transferring of the separation resin from the at least one first container to the second container.
Windahl teaches a system for transferring separation resin (1, Figure 1) between at least two containers, comprising:
a second container (3, Figure 1) comprising an inlet port (23, Figure 1) which is fluidically connected to the outlet port of said at least one first container (Figure 1, the first container (47) has an outlet port (Paragraph [0013]) above the slurry tank valve (45)); and
a pressure difference generating device (13 and 15, Figure 1, the actuator and the control unit are the pressure difference generating device) configured for transferring separation resin from the at least one first container (47, Figure 1) to the second container (3, Figure 1) by generating a pressure difference between an interior of the second container and an interior of the first container wherein the pressure is lower in the second container (Paragraph [0014]);
wherein the pressure difference pressure generating device (13 and 15, Figure 1) is at least one vacuum production device (Paragraph [0014]) connected to the second container (3, Figure 1) and arranged for providing a degree of vacuum in the second container at least during a transferring of the separation resin from the at least one first container to the second container (Paragraph [0014], suction is created when the pressure difference pressure generating device is raised causing the slurry to enter from the first tank to the second tank).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, and Niazi to include a second container comprising an inlet port which is fluidically connected to the outlet port of said at least one first container, a pressure difference generating device configured for transferring separation resin from the at least one first container to the second container by generating a pressure difference between an interior of the second container and an interior of the first container wherein the pressure is lower in the second container, and the pressure difference pressure generating device is at least one vacuum production device connected to the second container and arranged for providing a degree of vacuum in the second container at least during a transferring of the separation resin from the at least one first container to the second container as taught by Windahl with the motivation to apply the correct amount of compression to the predetermined amount of slurry that was removed to provide optimum performance of the column.
Hurst, Bungay, Windahl, and Niazi discloses the claimed invention except for the mechanical interaction device includes one or more movable parts configured to apply at least 5 deformations that each deform the first container by at least 5%. It would have been an obvious matter of design choice to deform the first container by at least 5% with at least 5 deformations, since applicant has not disclosed that the deformation of the first container by at least 5% with at least 5 deformations solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with deformation of the first container by at least 5% with at least 5 deformations applied to the first container.
Regarding Claim 21:
The above-discussed combination of Hurst, Bungay, Windahl, and Niazi accounts for this subject matter where Hurst discloses said at least one first container (30, Figure 1) is a flexible bag (Paragraph [0155]).
Regarding Claim 24:
The above-discussed combination of Hurst, Bungay, Niazi, and Windahl accounts for this subject matter where Windhal teaches said second container (3, Figure 1) is a separation device (Paragraph [0012]).
Regarding Claim 29:
Hurst discloses:
at least one container (30, Figure 1).
Hurst, Bungay, and Niazi do not teach:
wherein the at least one first container is connected to the second container by a transferring connection such that the separation resin initially provided in the at least one first container is transferred from the at least one first container to the second container through the transferring connection by the vacuum/under-pressure provided to the second container.
Windahl teaches:
wherein the at least one first container (47, Figure 1) is connected to the second container (3, Figure 1) by a transferring connection (43, Figure 1) such that the separation resin (Paragraph [0013]) initially provided in the at least one first container is transferred from the at least one first container (47, Figure 1) to the second container (3, Figure 1) through the transferring connection by the vacuum/under-pressure provided to the second container.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Niazi, and Bungay to include the at least one first container is connected to the second container by a transferring connection such that the separation resin initially provided in the at least one first container is transferred from the at least one first container to the second container through the transferring connection by the vacuum/under-pressure provided to the second container as taught by Windahl with the motivation to have a desired bed compression of the resin slurry.
Regarding Claim 31:
Hurst discloses:
at least one container (30, Figure 1).
Hurst, Bungay, and Niazi do not teach:
the transferring connection comprises at least one valve whereby opening of the at least one valve allows vacuum/under-pressure provided to the second container to affect the content in the first container such that the separation resin initially provided in the first container is transferred to the second container through the transferring connection.
Windahl teaches:
the transferring connection (43, Figure 1) comprises at least one valve (45, Figure 1) whereby opening of the at least one valve allows vacuum/under-pressure provided to the second container to affect the content in the first container such that the separation resin initially provided in the first container is transferred to the second container through the transferring connection (Paragraphs [0014-0015]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Niazi, and Bungay to include the transferring connection comprises at least one valve whereby opening of the at least one valve allows vacuum/under-pressure provided to the second container to affect the content in the first container such that the separation resin initially provided in the first container is transferred to the second container through the transferring connection as taught by Windahl with the motivation to allow and prevent slurry leaving the first container.
Regarding Claim 36:
Hurst discloses:
at least one container (30, Figure 1).
Hurst, Bungay and Niazi do not teach:
the second container comprises an adaptor defining the internal volume of the second container together with a bottom and internal walls of the second container, which adaptor is used as the pressure difference generating device by raising it within the second container thus increasing the internal volume of the second container.
Windahl teaches:
the second container (3, Figure 1) comprises an adaptor (9, Figure 1) defining the internal volume of the second container together with a bottom and internal walls of the second container (Paragraphs [0012] and [0014]), which adaptor is used as the pressure difference generating device by raising it within the second container thus increasing the internal volume of the second container (Paragraph [0014]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Niazi, and Bungay to include the second container comprises an adaptor defining the internal volume of the second container together with a bottom and internal walls of the second container, which adaptor is used as the pressure difference generating device by raising it within the second container thus increasing the internal volume of the second container as taught by Windahl with the motivation to have a desired packed bed height that is reproducible.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hurst in view of Bungay in further view of Niazi, Windahl, and Brandt (US 20110259831 A1).
Regarding Claim 22:
Hurst discloses:
said container (30, Figure 1) is configured for use in chromatography (Paragraph [0195]).
Hurst, Windahl, and Niazi do not teach:
said container system is configured for use in the packing of a column for manufacturing-scale separation of a biopharmaceutical.
Bungay teaches:
the container system (5, Figure 1).
Hurst, Niazi, Windahl, and Bungay do not teach:
said container system is configured for use in the packing of a column for manufacturing-scale separation of a biopharmaceutical.
Brant teaches a processing column system, comprising:
the packing of a column for manufacturing-scale separation of a biopharmaceutical (Paragraph [0002]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Windahl, and Niazi to include said container system is configured for use in the packing of a column for manufacturing-scale separation of a biopharmaceutical as taught by Brandt with the motivation to purify the product that is being produced while maintaining bed integrity.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Hurst in view of Bungay in further view of Niazi, Windahl and Telang (US 4388922 A).
Regarding Claim 26:
Hurst discloses:
said first container (30, Figure 1) can be connected sequentially or in parallel to withdraw fluid (Paragraph [0199]).
Hurst, Bungay, and Niazi do not teach:
the system comprises two or more first containers connected in series or in parallel and which are fluidically connected to the second container.
Windahl teaches:
the system (1, Figure 1) comprises second container (3, Figure 1) connected to the first container (47, Figure 1).
Hurst, Bungay, Niazi, and Windahl do not teach:
the system comprises two or more first containers connected in series or in parallel and which are fluidically connected to the second container.
Telang teaches a suction cannister system, comprising:
the system comprises two or more first containers (12 and 12a, Figure 1) connected in series or in parallel (Abstract) and which are fluidically connected to the second container (12b, Figure 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Niazi, and Windahl to include the system comprises two or more first containers connected in series or in parallel and which are fluidically connected to the second container as taught by Telang with the motivation to apply vacuum to the containers at the same time to fill the containers.
Regarding Claim 27:
Hurst discloses:
said first container (30, Figure 1) can be connected sequentially or in parallel to withdraw fluid (Paragraph [0199]).
Hurst, Bungay, and Niazi do not teach:
the outlet ports of the two or more first containers are connected to a resin transfer manifold which in turn is connected to the inlet of the second container.
Windahl teaches:
the system (1, Figure 1) comprises second container (3, Figure 1) connected to the outlet port (Paragraph [0013]) of the first container (47, Figure 1).
Hurst, Bungay, Niazi, and Windahl do not teach:
the outlet ports of the two or more first containers are connected to a resin transfer manifold which in turn is connected to the inlet of the second container.
Telang teaches:
a suction cannister system, comprising: the outlet ports (Figure 1, the outlet port are in the cover of the container) of the two or more first containers (12 and 12a, Figure 1) are connected to a resin transfer manifold (29 and 29a, Figure 1) which in turn is connected to the inlet of the second container (12b, Figure 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Niazi, and Windahl to include the outlet ports of the two or more first containers are connected to a resin transfer manifold which in turn is connected to the inlet of the second container as taught by Telang with the motivation to simultaneously apply vacuum to the containers.
Claims 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hurst in view of Bungay in further view of Niazi, Windahl and Gebauer (US 20130062267 A1).
Regarding Claim 28:
Hurst disclose:
the first container (30, Figure 1).
Hurst, Bungay, and Niazi do not teach:
the at least one first container comprising separation resin has been sterilized by gamma radiation and an interior of the second container has been sterilized before they are fluidically connected by aseptic connections.
Windahl teaches:
the system (1, Figure 1) comprises the second container (3, Figure 1) and the first container (47, Figure 1).
Hurst, Bungay, Niazi, and Windahl do not teach:
the at least one first container comprising separation resin has been sterilized by gamma radiation and an interior of the second container has been sterilized before they are fluidically connected by aseptic connections.
Gebauer teaches a packing system, comprising:
the at least one first container comprising separation resin has been sterilized by gamma radiation and an interior of the second container has been sterilized (Paragraphs [0024-0027] and [0064], the vessels and containers are sterilized with gamma radiation) before they are fluidically connected by aseptic connections (Paragraphs [0024-0027] and [0065]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Niazi, and Windahl to include the at least one first container comprising separation resin has been sterilized by gamma radiation and an interior of the second container has been sterilized before they are fluidically connected by aseptic connections as taught by Gebauer with the motivation to have a controlled level of microbiological burden to prevent contamination.
Regarding Claim 30:
Hurst discloses:
the first container (30, Figure 1).
Hurst, Bungay, and Niazi do not teach:
the transferring connection comprises disposable pre-sterilized connecting parts.
Windahl teaches:
the transferring connection (43, Figure 1).
Hurst, Bungay, and Niazi do not teach:
the transferring connection comprises disposable pre-sterilized connecting parts.
Gebauer teaches a packing system, comprising:
the transferring connection comprises disposable pre-sterilized connecting parts (Paragraphs [0024-0027] and [0064-0065], the lines and components are considered as the transferring connection).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Niazi, and Windahl to include the transferring connection comprises disposable pre-sterilized connecting parts as taught by Gebauer with the motivation to have a controlled level of microbiological burden to prevent contamination.
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Hurst in view of Bungay in further view of Niazi, Windahl, Freeman (US 4195672 A) and Friedrich (US 2999500 A).
Regarding Claim 32:
Hurst discloses:
the first container (30, Figure 1).
Hurst, Bungay, and Niazi do not teach:
the system further comprises a rinse bag connected to the first container, said rinse bag comprising a rinsing solution for rinsing the first container when the separation resin has been transferred to the second container, said rinsing solution being transferred from the rinse bag to the first container by the same pressure difference as generated between an interior of the second container and the first container for transferring the separation resin.
Windahl teaches:
the first container (47, Figure 1), the second container (3, Figure 1), separation resin (Paragraph [0014]) and a pressure difference between an interior of the second container and the first container for transferring the separation resin (Paragraph [0014]).
Hurst, Bungay, Niazi, and Windahl do not teach:
the system further comprises a rinse bag connected to the first container, said rinse bag comprising a rinsing solution for rinsing the first container when the separation resin has been transferred to the second container, said rinsing solution being transferred from the rinse bag to the first container by the same pressure difference as generated between an interior of the second container and the first container for transferring the separation resin.
Freeman teaches a transfer assembly, comprising:
the system further comprises a rinse bag connected to the first container, said rinse bag comprising a rinsing solution (Column 6, Lines 28-49) for rinsing the first container (E, Figure 13) when the separation resin (F, Figure 13) has been transferred to the second container, said rinsing solution being transferred to the first container by the same pressure difference as generated between an interior of the second container and the first container for transferring the separation resin (Column 6, Lines 37-47).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Niazi, and Windahl to include the system further comprises a rinse bag connected to the first container, said rinse bag comprising a rinsing solution for rinsing the first container when the separation resin has been transferred to the second container, said rinsing solution being transferred to the first container by the same pressure difference as generated between an interior of the second container and the first container for transferring the separation resinas taught by Freeman with the motivation to clean the conduits and containers in the system from contaminants.
Hurst, Windahl, Bungay, Niazi, and Moran fails to expressly teach:
a rinse bag.
Friedrich teaches a container for taking and storing biological fluids, comprising:
a bag (1, Figure 1) within a container (4, Figure 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Windahl, Niazi, and Freeman to include a bag within a container as taught by Friedrich with the motivation to easily replace the bag within the container to keep the bag sterile.
Through the combination, the rinse tank (116, Figure 13) of Freeman can have a bag within as seen in Friedrich to have the rinse bag.
Regarding Claim 33:
The above-discussed combination of Hurst, Bungay, Windahl, Freeman, Niazi, and Friedrich accounts for this subject matter where Freeman teaches wherein a rinse valve (110, Figure 13) is provided between the rinse tank (116, Figure 13) and the at least one first container (E, Figure 13) such that rinsing solution is transferred the rinse bag to the at least one first container (E, Figure 13) by the pressure difference generated between the first and second containers when the rinse valve is open (Column 6, Lines 28-49). Friedrich teaches a bag (1, Figure 1) within a container (4, Figure 1). Through the combination, the rinse tank (116, Figure 13) of Freeman can have a bag within as seen in Friedrich to have the rinse bag.
Claims 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Hurst in view of Bungay in further view of Niazi, Windahl, Moran (US 6402958 B1), and Karlberg (US 20110053127 A1).
Regarding Claim 34:
Hurst discloses:
the first container (30, Figure 1).
Hurst, Bungay, and Niazi do not teach:
the second container is a chromatography column connected to a liquid supply system such that the separation resin is fluidized within the second container by the liquid supply system.
Windahl teaches:
the second container (3, Figure 1) is a chromatography column (Paragraph [0012]).
Hurst, Bungay, Niazi, and Windahl do not teach:
the second container is a chromatography column connected to a liquid supply system such that the separation resin is fluidized within the second container by the liquid supply system.
Moran teaches a chromatography column method, comprising:
the second container is a chromatography column connected to a liquid supply system such that the separation resin is fluidized (Column 3, Lines 19-27, the fluidization of the slurry occurs when the solvent goes through the column) within the second container by the liquid supply system (Column 3, Lines 35-37, the liquid supply system is the circulation of the solvent).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Niazi, and Windahl to include the second container is a chromatography column connected to a liquid supply system such that the separation resin is fluidized within the second container by the liquid supply system as taught by Moran with the motivation to distribute the solvent and eliminate the dead spots before the compressing the absorbent.
Hurst, Windahl, Bungay, Niazi, and Moran fails to expressly teach:
a liquid supply system.
Karlberg teaches a column packing method, comprising:
a liquid supply system (14, Figure 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Moran, Niazi, and Windahl to include a liquid supply system as taught by Karlberg with the motivation to pump liquid into the column to create a compressed column.
Regarding Claim 35:
Hurst discloses:
the first container (30, Figure 1).
Hurst, Windahl, Niazi, and Bungay do not teach:
the second container comprises a liquid distribution system at an inlet for the liquid supply system hereby improving a homogenization of the slurry provided by the fluidization.
Moran teaches:
the second container is a chromatography column connected to the liquid supply system (Column 3, Lines 35-37, the liquid supply system is the circulation of the solvent).
Hurst, Windahl, Bungay, Niazi, and Moran do not teach:
the second container comprises a liquid distribution system at an inlet for the liquid supply system hereby improving a homogenization of the slurry provided by the fluidization.
Karlberg teaches:
the second container (7, Figure 1) comprises a liquid distribution system (5 b, Figure 1) at an inlet for the liquid supply system hereby improving a homogenization of the slurry provided by the fluidization (Paragraph [0030]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Moran, Niazi, and Windahl to include the second container is a chromatography column connected to a liquid supply system such that the separation resin can be fluidized within the second container by the liquid supply system as taught by Karlberg with the motivation to distribute incoming liquid evenly over the column.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable Hurst in view of Bungay in further view of Niazi, Windahl and Brandt.
Regarding Claim 38:
Hurst discloses:
said container (30, Figure 1) is configured for use in chromatography (Paragraph [0195]).
Hurst, Bungay, and Niazi do not teach:
said system is configured for use in the packing of a column for manufacturing- scale separation of a biopharmaceutical.
Windahl teaches:
the system (1, Figure 1) is configured for use in the packing of a column (Paragraphs [0014-0015]).
Hurst, Bungay, Windahl, and Niazi do not teach:
said system is configured for use in the packing of a column for manufacturing- scale separation of a biopharmaceutical.
Brandt teaches a processing column system, comprising:
the packing of a column for manufacturing-scale separation of a biopharmaceutical (Paragraph [0002]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hurst, Bungay, Niazi, and Windahl to include said system is configured for use in the packing of a column for manufacturing- scale separation of a biopharmaceutical as taught by Brandt with the motivation to purify the product that is being produced while maintaining bed integrity.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vicalvi (US 10463988 B2) teaches a chromatography system comprising a resin slurry, a single-use bag, a first container, and an outlet for the first container.
Gebauer 2 (US 20140224738 A1) teaches packing of chromatography columns comprising a flexible container, separation resin, storage solution, and a second container.
Hermansson (US 20080017579 A1) teaches an axial chromatography column comprising a second container, and an adapter.
Mauger 2 (US 8157127 B2) teaches a method of draining a flexible container comprising a storage container, a first container, a bag, and an air bladder.
Hlavinka (US 20060176767 A1) teaches a container or bag mixing apparatus comprising a bag and a mechanical interaction device.
Hubbard (US 7377686 B2) teaches a disposable mixing system comprising a flexible bag and a mechanical interaction device.
Tysiac (US 20100243670 A1) teaches a polishing apparatus comprising a deformable, single-use first container and the fluidization of the slurry when the bag is being deformed.
Singh (US 6544788 B2) teaches a disposable perfusion bioreactor for cell culture comprising a bag, a mechanical interaction device and resin.
Lee (US 8469238 B2) teaches an apparatus for dispensing resin comprising a first container, a second container and multiple valves.
Runyon (US 7682823 B1) teaches bioreactor system comprising a bag, separation resin and mixing of the separation resin.
Avallin (US 10940402 B2) teaches a method and system for transferring separation resin comprising a first container, a second container, a mechanical interaction device, and multiple valves.
Edbald (US 8066882 B2) teaches a column packing method comprising a first container, a second container, a controller, and a pressure difference generating device.
Singh (US 6544788 B2) teaches a disposable perfusion bioreactor comprising a bag, an inlet, an outlet, sterilization of the bag, and rocking of the bag.
Baron (US 6637929 B2) teaches a method for agitating a fluid suspension comprising a bag, a storage bin, and a mechanical interaction device in the bottom of the storage bin to mix the fluid.
Hubbard (US 7377686 B2) teaches a disposable mixing system comprising a bag, a storage bin, and a mechanical interaction device.
Luther (US 2724508 A) teaches a separator for solid-liquid slurry comprising a flexible container, a rigid container, and a slurry.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/STEPHANIE A SHRIEVES/Examiner, Art Unit 3753
/DAVID COLON-MORALES/Primary Examiner, Art Unit 3753
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